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镥 177 放射性药物维泊妥组单抗：首次获批

Lutetium Lu 177 Vipivotide Tetraxetan: First Approval.

机构信息

Springer Nature, Mairangi Bay, Private Bag 65901, Auckland, 0754, New Zealand.

出版信息

Mol Diagn Ther. 2022 Jul;26(4):467-475. doi: 10.1007/s40291-022-00594-2. Epub 2022 May 13.

DOI:10.1007/s40291-022-00594-2
PMID:35553387
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9099330/
Abstract

Lutetium Lu 177 vipivotide tetraxetan (PLUVICTO™, formerly known as Lu-PSMA-617) is a radioligand therapeutic agent that is being developed by Advanced Accelerator Applications (a subsidiary of Novartis) for the treatment of prostate-specific membrane antigen (PSMA)-expressing metastatic prostate cancer. The active part of the radiopharmaceutical is lutetium-177, which is linked to a ligand that binds to prostate-specific membrane antigen (PSMA), a transmembrane enzyme overexpressed in primary and metastatic prostate cancers. Based on efficacy results from the phase 3 VISION trial, lutetium Lu 177 vipivotide tetraxetan was approved in the USA on 23 March 2022 for the treatment of adult patients with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor (AR) pathway inhibition and taxane-based chemotherapy. Regulatory review in the EU and other countries is underway. This article summarizes the milestones in the development of Lutetium Lu 177 vipivotide tetraxetan leading to this first approval as a therapeutic radioligand for mCRPC.

摘要

镥 177 标记的 VIPivotide Tetraxetan（PLUVICTO™，前称 Lu-PSMA-617）是一种放射性配体治疗药物，由先进加速器应用公司（诺华子公司）开发，用于治疗前列腺特异性膜抗原（PSMA）表达的转移性前列腺癌。放射性药物的活性部分是镥 177，它与一种配体连接，该配体与前列腺特异性膜抗原（PSMA）结合，PSMA 是一种在原发性和转移性前列腺癌中过度表达的跨膜酶。基于 III 期 VISION 试验的疗效结果，镥 177 标记的 VIPivotide Tetraxetan 于 2022 年 3 月 23 日在美国获得批准，用于治疗已接受雄激素受体（AR）通路抑制和紫杉烷类化疗的 PSMA 阳性转移性去势抵抗性前列腺癌（mCRPC）成年患者。在欧盟和其他国家的监管审查正在进行中。本文总结了镥 177 标记的 VIPivotide Tetraxetan 开发过程中的重要里程碑，最终使其作为 mCRPC 的治疗性放射性配体获得首次批准。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/61f7/9099330/fbb9f89646e0/40291_2022_594_Figa_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/61f7/9099330/bc15ee804f7a/40291_2022_594_Figb_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/61f7/9099330/fbb9f89646e0/40291_2022_594_Figa_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/61f7/9099330/bc15ee804f7a/40291_2022_594_Figb_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/61f7/9099330/fbb9f89646e0/40291_2022_594_Figa_HTML.jpg

相似文献

[1]
Lutetium Lu 177 Vipivotide Tetraxetan: First Approval.

Mol Diagn Ther. 2022-7

[2]
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[3]
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[4]
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[5]
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[6]
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[7]
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[8]
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[9]
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本文引用的文献

[1]
Biomarkers to personalize treatment with 177Lu-PSMA-617 in men with metastatic castration-resistant prostate cancer - a state of the art review.

Ther Adv Med Oncol. 2022-3-5

[2]
Lu-PSMA-617 versus docetaxel in chemotherapy-naïve metastatic castration-resistant prostate cancer: a randomized, controlled, phase 2 non-inferiority trial.

Eur J Nucl Med Mol Imaging. 2022-4

[3]
177 Lu-PSMA-617 radioligand therapy of metastatic castration-resistant prostate cancer: Initial 254-patient results from a prospective registry (REALITY Study).

Eur J Nucl Med Mol Imaging. 2022-2

[4]
Circulating androgen receptor gene amplification and resistance to Lu-PSMA-617 in metastatic castration-resistant prostate cancer: results of a Phase 2 trial.

Br J Cancer. 2021-10

[5]
Lu-PSMA617 and the VISION Trial: One of the Greatest Success Stories in the History of Nuclear Medicine.

J Nucl Med. 2021-8-1

[6]
Lu-PSMA-617 and Idronoxil in Men with End-Stage Metastatic Castration-Resistant Prostate Cancer (LuPIN): Patient Outcomes and Predictors of Treatment Response in a Phase I/II Trial.

J Nucl Med. 2022-4

[7]
Intra-therapeutic dosimetry of [Lu]Lu-PSMA-617 in low-volume hormone-sensitive metastatic prostate cancer patients and correlation with treatment outcome.

Eur J Nucl Med Mol Imaging. 2022-1

[8]
Renal Safety of [Lu]Lu-PSMA-617 Radioligand Therapy in Patients with Compromised Baseline Kidney Function.

Cancers (Basel). 2021-6-21

[9]
Lutetium-177-PSMA-617 for Metastatic Castration-Resistant Prostate Cancer.

N Engl J Med. 2021-9-16

[10]
Prospective phase 2 trial of PSMA-targeted molecular RadiothErapy with Lu-PSMA-617 for metastatic castration-reSISTant Prostate Cancer (RESIST-PC): efficacy results of the UCLA cohort.

J Nucl Med. 2021-10

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